Issue guidance, Workshop, Training, Communication back and forth with Industry;

Case studies from Industry.

·

Team review-inspection will help.

Note: Portions of the above notes were used in preparing the "Summary of Discussions" of Product and Process Development Working Group deliberations. Dr. Judy P. Boehlert presented the "Summary of Discussions" to the PAT Subcommittee, in the afternoon session of the meeting, on June 13, 2002. That document can be found on FDA's website, http://www.fda.gov/ohrms/dockets/ac/acmenu.htm.